Physical Activity, Fatigue, Social Support, and Psychological Well-Being in Women With Primary Hypothyroidism

NCT07408765 | Recruiting

• 1 other identifier: HipotAct
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Primary hypothyroidism, both clinical and subclinical, is frequently associated with persistent fatigue, reduced psychological well-being, and lower levels of physical activity in adult women. However, evidence integrating these psychosocial factors remains limited and methodologically heterogeneous. Objective. To analyze the association between physical activity and fatigue, social support, and psychological well-being in women with primary hypothyroidism; to compare these profiles between clinical and subclinical hypothyroidism; and to explore the moderating effect of social support and psychological well-being on the relationship between fatigue and physical activity. Methods. An observational, analytical, multicenter cohort study will be conducted including 96 adult women with primary hypothyroidism from the Principality of Asturias. Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), while fatigue, social support, and psychological well-being will be measured using the Fatigue Severity Scale (FSS), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the WHO-5 Well-Being Index, respectively. Confounding variables will include age, body mass index, type of hypothyroidism (clinical or subclinical), and time since diagnosis. Descriptive analyses, comparisons between clinical and subclinical groups, and multiple linear regression models will be performed. Expected results. The study is expected to identify physical activity levels within the sample and determine which psychosocial factors are independently associated with physical activity. Additionally, fatigue is anticipated to be negatively associated with physical activity, whereas social support and psychological well-being are expected to show positive associations and potential moderating effects.

Conditions

Hypothyroidism Primary

Keywords

Female; Hypothyroidism; Physical activity; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Measurement of habitual physical activity level

  This variable will be assessed using the Spanish version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This instrument, widely used in clinical and population-based research, allows estimation of weekly energy expenditure in MET-minutes and classification of participants into low, moderate, or high physical activity categories.

  Screening visit

Secondary Outcomes (3)

• Measurement of perceived fatigue

  Screening visit

• Measurement of perceived social support

  Screening visit

• Measurement of psychological well-being

  Screening visit

Other Outcomes (4)

• Measurement of age

  Screening visit

• Measurement of body mass index

  Screening visit

• Measurement of type of hypothyroidism

  Screening visit

Study Arms (1)

Observational group

Women with primary hypothyroidism from the Principality of Asturias

Other: Women with primary hypothyroidism sample

Interventions

Women with primary hypothyroidism sample OTHER

To assess the level of physical activity in women with primary hypothyroidism and to identify the predictive model of physical activity in this population.

Observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with primary hypothyroidism

You may qualify if:

• Have a diagnosis of primary hypothyroidism (clinical or subclinical), established by a specialist in Endocrinology or Internal Medicine based on TSH and FT4 levels.
• Female.
• Have stable treatment for thyroid dysfunction (levothyroxine dose or other replacement regimen without relevant modifications) for at least the previous 3 months, or a stable clinical condition if treatment is not required.
• Are able to ambulate independently in the community (with or without usual assistive devices), allowing participation in light to moderate physical activity.
• Are able to understand and complete the questionnaires independently.
• Have provided written informed consent

You may not qualify if:

• Have a diagnosis of severe medical conditions that predominantly limit the ability to perform physical activity independently of hypothyroidism (e.g., advanced heart failure, severe chronic respiratory disease).
• Have severe psychiatric disorders or significant cognitive impairment that hinder understanding of the information or reliable completion of the questionnaires.
• Have undergone major surgery, severe trauma, or an acute medical condition that has substantially limited physical activity in the three months prior to assessment.
• Are pregnant or in the immediate postpartum period, due to potential hormonal and functional interference with the study variables.
• Are concurrently participating in a clinical trial or a structured physical exercise program.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

RECRUITING

MeSH Terms

Conditions

Hypothyroidism; Motor Activity

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Behavior

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

0034 985103386; cuestaruben@uniovi.es

Rubén Cuesta-Barriuso, PhD

CONTACT

cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: February 16, 2026
• Primary Completion: April 28, 2026
• Study Completion: May 15, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

ES (1)